Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study

Pulmonary Hypertension Clinical Trial

— MRI-HART  

Official title:

Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377934
• Other study ID #: RT2011-02
• Status: Completed
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: November 2022
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the tumour is limited by the risk of radiation induced lung damage. This damage is characterized by parenchymal damage and vascular damage. In rats, we have found that radiation-induced vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent loss of pulmonary function could be fully explained by this increase in pulmonary artery pressure. We hypothesize that also in patients a radiation induced increase in pulmonary artery pressure can be observed after radiotherapy, which may contribute to the development of radiation pneumonitis. The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• WHO PS 0-2
• Histological or cytological confirmation of non-small cell lung cancer or an 18F-FDG-positive, growing mass on CT-thorax suggestive of NSCLC.
• Stage IIIA or IIIB
• Patients with extensive mediastinal lymph node involvement (such as N3), or large primary tumour size
• Adequate pulmonary function estimated by flow volume curves
• Life expectancy of at least 6 months
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.
• Planned for 25 x 2.4 Gy, with concomitant chemotherapy
• Before patient registration, written informed consent will be obtained.

Exclusion Criteria:

• Presence of contra-indications for undergoing MRI

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Radiation:
• Cardiac Magnetic Resonance Imaging (MRI)

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pulmonary artery pressure		6 and 12 weeks after completion chemoradiotherapy
Secondary	Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function		6 and 12 weeks after completion chemoradiotherapy
Secondary	The assessment of RV-dimensions and RV-function		6 and 12 weeks after completion chemoradiotherapy
Secondary	The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria		6 weeks after completion treatment
Secondary	The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0		12 weeks after completion of treatment